BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society – Yahoo Finance

NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that the Company has received a $495,330 grant from the National Multiple Sclerosis Society, through its Fast Forward program, to advance BrainStorms Phase 2 open-label, multicenter clinical trial of repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (NCT03799718).

Chaim Lebovits, President and CEO of BrainStorm stated, We are very pleased to receive this generous grant from the National MS Society. Currently, we are conducting our Phase 2 study in three leading US medical centers: The Keck School of Medicine of USC, The Stanford School of Medicine, and Cleveland Clinic. This research funding will help advance our investigational therapy NurOwn as a potential unmet need for patients with progressive MS. MS continues to devastate the lives of patients and their families and we thank the National MS Society for helping us advance our innovative research program.

Currently, progressive MS treatment options are limited and NurOwn is a promising new autologous cellular treatment modality that has the potential to directly address MS disease pathways, said Ralph Kern MD MHSc, COO and CMO of BrainStorm. He added, This funding from the National MS Society will help us explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwns unique mechanism of action and guide the design of future clinical trials to address this important unmet patient need.

Leveraging resources in this Phase 2 clinical study of a cell-based therapy for progressive MS exemplifies our work to accelerate research to improve clinical care for people living with MS. said Mark Allegretta, PhD, Vice President of Research at the National MS Society. Were pleased to work with BrainStorm to test a broad panel of biomarkers of neuroinflammation and repair as correlates of the effect of treatment with NurOwn.

About Multiple SclerosisMultiple sclerosis is an unpredictable, often disabling disease of the central nervous system. There is currently no cure for MS. Symptoms vary from person to person and range from numbness and tingling, to mobility challenges, blindness and paralysis. An estimated 1 million people live with MS in the United States. Most people are diagnosed between the ages of 20 and 50 and it affects women three times more than men.

About The National Multiple Sclerosis Society:The National MS Society, founded in 1946, funds cutting-edge research, drives change through advocacy, and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 1-800-344-4867.

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com.

Story continues

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

More here:
BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society - Yahoo Finance

BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update – GlobeNewswire

Conference Call and Webcast Today at 8:00 a.m. Eastern Time

Highlights Include: ALS Phase 3 Clinical Trial Fully Enrolled, Data Safety Monitoring Board Recommends ALS Phase 3 Clinical Trial Continue, Appointment of CFO, Phase 2 in Progressive MS Continues to Enroll Patients

NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2019 and recent corporate updates.

On October 11, 2019 we reached a major corporate milestone by fully enrolling 200 patients in the Phase 3 clinical trial of NurOwn in ALS (Amyotrophic Lateral Sclerosis). Additionally, on October 28, we announced that we received notification from the NurOwn Data Safety Monitoring Board (DSMB) that after reviewing all of the safety data as of September 30, the study should continue without any changes in the protocol. The DSMB indicated they did not identify any significant safety concerns, stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. He added, Our Phase 2 trial of NurOwn in Progressive MS (Multiple Sclerosis) continues to enroll patients in several of the leading U.S. medical centers and we anticipate announcing additional investigational centers of excellence in the near future. The first eight (8) participants have been enrolled in the study.

Third Quarter 2019 and Recent Corporate Highlights:

Financial Results for the Three Months Ended September 30, 2019

For further details on BrainStorms financials, including financial results for the three months ended September 30, 2019, refer to Form 10-Q filed with the SEC on November 14th, 2019.

Conference Call and Webcast: Thursday, November 14, 2019 @ 8:00 a.m. Eastern Time

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe-Harbor StatementStatements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)U.S. dollars in thousands(Except share data)

View original post here:
BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update - GlobeNewswire

BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting – Yahoo Finance

NEW YORK, Nov. 12, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Companys Chief Operating and Chief Medical Officer Ralph Kern MD MHSc will present at the 7th International Stem Cell Meeting, which is hosted by the Israel Stem Cell Society. The Conference will be held November 12-13, in Tel Aviv, Israel.

Ralph Kern, MD, MHSc, said: I welcome the opportunity to participate in the 7th International Stem Cell Meeting where I will share the advances BrainStorm has made with NurOwn. It is a privilege to participate and to exchange ideas with many of the international scientific leaders in stem cell research.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Story continues

Read the original here:
BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting - Yahoo Finance

INDIA Indian doctor: Medical innovation should not try to replace the Creator – AsiaNews

Dr Pascoal Carvalho addressed the 21st convention of Indias Catholic nurses in Mumbai. He spoke about the ethical aspects of genetic engineering, citing the doctrine of the Church towards human cloning and stem cells. Respect for human dignity must prevail from conception to natural death.

Mumbai (AsiaNews) Medical innovation, which increasingly uses modern technologies to improve life, should not attempt to artificially replicate creation, said Dr Pascoal Carvalho, a doctor from Mumbai and a member of the Pontifical Academy for Life, speaking at the 21st convention of Catholic nurses (8-10 November).

In his address on 9 November, he referred to therapeutic cloning, stem cells and modified human DNA before an audience of more than 200 Catholic health workers.

"[W]e can rest assured in the wisdom of the Church," he said, because for her, The dignity of a person must be recognized in every human being from conception to natural death.

Some areas of medical research that raise serious moral and ethical questions touch stem cells, embryos and DNA.

In his view, today There is a growing threat of overestimating genetic modification techniques and underestimating the repercussions of cloning and human gene therapy.

On the one hand, we have the positive results of therapeutic cloning aimed at organ and tissues reconstructed in laboratory for transplanting into patients to reduce the risk of rejection; on the other, reproductive cloning, like in the case of Dolly the sheep, seeks to reproduce living beings.

He warns against research that leads to alterations in an organisms DNA, like the famous case of the Chinese scientist who in 2018 said that he had created two twins in the laboratory immune to the HIV virus. This kind of experiment can reduce life expectancy and increase susceptibility to other, and perhaps more common, diseases.

The doctor cites the Dignitas Personae, which defines any attempt at human cloning as unacceptable, because it represents a serious offense to the dignity of the person and fundamental equality between men.

As for therapeutic cloning, To create embryos with the intention of destroying them, even with the intention of helping the sick, is completely incompatible with human dignity, because it makes the existence of a human being at the embryonic stage nothing more than a means to be used and destroyed. It is gravely immoral to sacrifice a human life for therapeutic ends.

Citing the doctrine of the Church, Dr Carvalho stresses the importance of the method with which stem cells are taken. In his view, Methods which do not cause serious harm to the subject from whom the stem cells are taken are to be considered licit.

This is generally the case when tissues are taken from: a) an adult organism; b) the blood of the umbilical cord at the time of birth; c) foetuses who have died of natural causes.

Overall, the doctor believes that modern gene technologies raise new moral questions, whilst attempts to create a new type of human being contains an ideological element in which man tries to take the place of his Creator.

Read more here:
INDIA Indian doctor: Medical innovation should not try to replace the Creator - AsiaNews

Contrasting BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) – DFS Caller

BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (NASDAQ:LVGO) are both medical companies, but which is the better stock? We will compare the two companies based on the strength of their risk, analyst recommendations, institutional ownership, valuation, dividends, earnings and profitability.

Profitability

This table compares BioRestorative Therapies and Livongo Healths net margins, return on equity and return on assets.

Analyst Ratings

This is a breakdown of recent ratings for BioRestorative Therapies and Livongo Health, as reported by MarketBeat.

Livongo Health has a consensus target price of $44.30, indicating a potential upside of 65.86%. Given Livongo Healths higher probable upside, analysts clearly believe Livongo Health is more favorable than BioRestorative Therapies.

Valuation & Earnings

This table compares BioRestorative Therapies and Livongo Healths revenue, earnings per share (EPS) and valuation.

BioRestorative Therapies has higher earnings, but lower revenue than Livongo Health.

Institutional & Insider Ownership

0.3% of Livongo Health shares are held by institutional investors. 17.9% of BioRestorative Therapies shares are held by insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a company will outperform the market over the long term.

Summary

Livongo Health beats BioRestorative Therapies on 7 of the 9 factors compared between the two stocks.

BioRestorative Therapies Company Profile

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells for the treatment of disc/spine disease and metabolic disorders. The company's lead cell therapy candidate is the BRTX-100, which focuses on providing non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. It also develops the ThermoStem program, a pre-clinical program for the treatment of metabolic diseases, such as type 2 diabetes, obesity, hypertension, and other metabolic disorders, as well as cardiac deficiencies. In addition, the company provides curved needle device, a needle system with a curved inner cannula that allows access to difficult-to-locate regions for the delivery or removal of fluids and other substances. Further, it offers skin care products under the Stem Pearls brand name. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; and a research agreement with Pfizer, Inc. and the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. BioRestorative Therapies, Inc. was incorporated in 1997 and is headquartered in Melville, New York.

Livongo Health Company Profile

Livongo Health, Inc. provides an integrated suite of solutions for the healthcare industry in North America. It solutions promote health behavior change based on real-time data capture supported by intuitive devices and insights driven by data science. The company offers a platform that provides cellular-connected devices, supplies, informed coaching, data science-enabled insights, and facilitates access to medications. Its products include Livongo for Diabetes, Livongo for Hypertension, Livongo for Prediabetes and Weight Management, and Livongo for Behavioral Health by myStrength. The company was formerly known as EosHealth, Inc. and changed its name to Livongo Health, Inc. in 2014. Livongo Health, Inc. was incorporated in 2008 and is headquartered in Mountain View, California.

Excerpt from:
Contrasting BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) - DFS Caller

iCell Gene Therapeutics Announces CAR-T Oral and Poster Presentations at 61st American Society of Hematology Annual Meeting – Send2Press Newswire

STONY BROOK, N.Y., Nov. 14, 2019 (SEND@PRESS NEWSWIRE) iCell Gene Therapeutics, a clinical stage biopharmaceutical company focused on immunotherapies for hematologic malignancies, solid tumors, organ rejections and autoimmune disorders, announced today that it will give oral and poster presentations related to its BCMA-CD19 cCAR and CD4-specific CAR programs at the 61st American Society of Hematology (ASH) Annual Meeting to be held December 7-10, 2019 in Orlando, Florida.

ASH abstracts are now available at https://www.hematology.org/.

Oral Presentation:

Title: First-in-Human Trial of BCMA-CD19 Compound CAR with Remarkable Donor-Specific Antibody ReductionSession:721. Abstract Number: 38Saturday, December 7, 2019: 7:45 a.m.Valencia BC (W415BC), Level 4 (Orange County Convention Center)Clinicaltrials.govID: NCT04162353

Poster Presentation:

Title: First-in-Human CD4 CAR Clinical Trial on Peripheral T-Cell LymphomaSession:626. Abstract Number: 2881Sunday, December 8, 2019, 6 p.m. to 8 p.m.Hall B, Level 2 (Orange County Convention Center)Clinicaltrials.govID: NCT04162340

About BCMA-CD19 cCAR therapy

BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. The diseases treated by BCMA-CD19 cCAR could include autoimmune disorders, and organ rejection. BCMA is expressed in plasma cells, while CD19 is related to B-cells. BCMA-CD19 cCAR is designed to completely remove antibody-producing roots, plasma cells and B cells, and then re-set the immune system for treating antibody-mediated autoimmune disorders or organ rejections.

BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.

About CD4-specific CAR (CD4 CAR) therapy

CD4-specific CAR with a safety switch is designed to treat peripheral T cell lymphoma as CD4 is uniformly expressed on most mature T cell lymphoma, and transient depletion of CD4 is expected. The diseases treated by CD4 CAR could include peripheral T-cell lymphoma (NOS), Sezary syndrome/cutaneous T-cell lymphoma, angioimmunoblastic T-cell lymphoma, adult T cell lymphoma, T-cell prolymphocytic leukemia, T-cell acute lymphoblastic leukemia/lymphoma and T-cell large granular lymphocytic leukemia. Most of these diseases are difficult to treat, with dismal prognoses. An IND has been approved for iCell Gene Therapeutics to initiate a multi-site clinical trial at Stony Brook University Hospital and University of Louisville.

iCell Gene Therapeutics, located in Stony Brook, New York, is a clinical-stage biopharmaceutical company developing first-in-class chimeric antigen receptor engineered cells. Clinical studies on our CARvac, T-cell targeted CARs, Compound CARs, Non-gene edited universal CARs and C-TPS1 (depletion of TREG, blockage of PD-L1 pathways and stimulation of tumor infiltrating lymphocytes) for solid tumors are ongoing in the US and in China.

For more information, please visithttp://icellgene.com/

Contact:Media and InvestorsKevin PinzTel: (631) 538-6218Kevin.pinz@icellgene.com

News Source: iCell Gene Therapeutics LLC

Read the original here:
iCell Gene Therapeutics Announces CAR-T Oral and Poster Presentations at 61st American Society of Hematology Annual Meeting - Send2Press Newswire

Is Stem Cell Therapy for Hip Arthritis Safe and Effective? – The African Exponent

What are stem cells?

Stem cells are the raw cells of the body. Essentially, this means that the stem cells are the cells from which all other specialized cells are derived. The specialty of stem cells is that they are able to become any cell in the body. The cells of the heart, the cells of the liver, the cells of the kidney all come from the basic stem cells. Any cell that has been derived from a stem cell is called a daughter cell. Stem cells can be made to develop and divide into daughter cells in the right laboratory conditions. In recent years, there have been a lot of research about stem cell transplant for arthritis.

Is stem cell therapy safe?

Stem cell therapy is considered much safer than traditional procedures that may involve implantations. The reason for this increased safety is because of the bodys immune system. The bodys immune system is always on high alert to intercept and destroy any foreign particle in the body. Because in an implant, you are placing a foreign object in the body, there are chances that there will be rejection or high wear and tear of these objects. The success rate of stem cell therapy for hips is very high because stem cells are a part of our own body. They have our DNA, and because of that, they are not considered as foreign particles.

How do stem cells help in managing and curing arthritis?

When they are applied to an arthritic joint, the stem cells might start becoming cartilage cells that are required in the hip joint. The main reason for extreme pain in the hip joints of a person with arthritis is the degeneration of cartilage. The cartilage is a tissue that is similar to bone and helps keep the bones intact, and the hip to move freely.

The cartilage cells often become hard and brittle because of old age and start wearing out with passing time. Stem cell transplant for arthritis works by considering that the stem cells can become any specialized cell in the human body, doctors think that the stem cells will either become new cartilage cells and replace the old ones. Or the stem cells will help in slowing down the aging of the cartilage by releasing certain proteins (called cytokines). This slowing down will help reduce the pain of arthritis in the patient. When it comes to stem cell therapy vs. hip replacement surgery, It looks like stem cell therapy has a smaller number of complications that are associated with it.

The only risk of complication with using stem cell therapy for hip arthritis is swelling and infection. Infection and swelling are also major risks of having traditional hip replacement surgery. Swelling can be controlled with a few drugs that help in blood flow and will not hamper the healing of the patient. Infection, on the other hand, may pose a bigger problem and threat later on for the health. In stem cell therapy, the infection could happen if the wrong types of stem cells, for example. Pluripotent stem cells are used instead of adult stem cells. When it comes to traditional hip replacement surgery, the infection can be because of the implantation of an infected hip joint or because of the entry of any foreign particle through the cuts that have been made for the implant surgery. Considering all these factors, stem cell transplant for arthritis looks like a safer and better option.

Am I eligible for stem cell therapy for hip arthritis?

Firstly, there are not many centers around the world that have mastered the art of treating hip arthritis with stem cell therapy. There are a few surgeons and doctors who have performed stem cell therapy successfully for hip arthritis with satisfactory results. You should try and approach doctors who have already done this treatment first and have performed them with ease.

There are a lot of serious conditions that have been met with the patient who wants to take the option for stem cell transplant for arthritis. Firstly, the patient must be stable enough to undergo stem cell therapy. The stem cells have to be harvested first for this treatment to work. Harvesting may not be possible in all patients, and the patient may not be able at times to take this route of treatment for curing hip arthritis.

Is there any research going on for stem cell therapy for hip-related conditions?

There is a lot of research that is going on to identify diseases that can be cured by stem cell therapy. One of the hotly researched topics is stem cell transplant for arthritis. It will not be a very long time before stem cell therapy will become the go-to option to cure people of hip-related arteritis and other related conditions. Extensive research is happening in all major universities as well as pharmaceutical companies regarding stem cell transplant for arthritis.

Read more here:
Is Stem Cell Therapy for Hip Arthritis Safe and Effective? - The African Exponent

Jury Hands Down $42.5M Total Verdict Against Philip Morris and RJR in Retrial Over Smoker’s Cancer Death – CVN News

Stock image.

Miami, FL R.J. Reynolds and Philip Morris were hit with a $42.5 million total verdict in a retrial over the 1996 cancer death of a Florida smoker. Gloger v. R.J. Reynolds and Philip Morris, 2011-CA-23377.

The award includes $15 million in compensatories awarded Friday, as well as an $11 million punitive award imposed against Philip Morris and $16.5 million in punitives imposed against Reynolds Wednesday for the responsibility jurors found the companies bore for Irene Glogers lung cancer.

Gloger, who had smoked for decades, died at 47, about a year after she quit smoking. Her family contends a tobacco industry-wide conspiracy to hide the dangers of smoking throughout much of the 20th century hooked Gloger to cigarettes and ultimately led to her fatal cancer.

The verdictmore than doubles the $17.5 million jurors awarded in a 2018, CVN-covered trial of the case. That verdict was thrown out in March by Floridas Third District Court of Appeal, which found the trial court had not not properly limited Kenneth Glogers testimony concerning conversations he had with his wifes doctors.

The Gloger case is among thousands that stem from Engle v. Liggett Group Inc., a 1994 Florida state court class-action lawsuit against Philip Morris and other tobacco companies. The state's supreme court ultimately decertified the class, but ruled that so-called Engle progeny cases may be tried individually. Plaintiffs are entitled to the benefit of the jury's findings in the original verdict, including the determination that tobacco companies placed a dangerous, addictive product on the market and conspired to hide the dangers of smoking.

However, in order to be entitled to those findings, plaintiffs must prove the smokers at the heart of their cases suffered from nicotine addiction that caused a smoking-related illness.

The origin of Glogers cancer, as well as what, if any responsibility she bore for her smoking, served as key battle lines in the 12-day trial.

During Fridays closings in the trials first phase, on Engle class membership, King & Spaldings Cory Hohnbaum, representing Reynolds, challenged the claim that Gloger had smoking-related lung cancer, and argued that a mass was never found in Glogers lung. He also contended doctors could not agree on the cell-type of Glogers cancer.

There is confusion, massive confusion among the pathologists about what this was, Hohnbaum said, noting Gloger saw several pathologists during her treatment. You dont need to go talk to multiple pathologists if the pathology is clear. It was never clear.

Arnold & Porters Keri Arnold, representing Philip Morris, added that, regardless of the cancers origin, Gloger knew the dangers of cigarettes, yet chose to continue smoking. Arnold noted that Gloger had been smoking for years by the time she began smoking Philip Morris brand cigarettes. She was an adult, she was married, she had a family, she was a medical professional. She had all the maturity and information she needed to make her own decisions about her own smoking and her own health, Arnold said.

But the Gloger familys attorney, The Ratzan Law Groups Stuart Ratzan, argued Gloger was heavily addicted to cigarettes and unable to stop in time to avoid her cancer. Ratzan walked jurors through Glogers smoking history, which included numerous failed quit attempts. Theres no reason no reason at all for a person to coat their lungs every 30 or 40 minutes, a pack-and-a-half a day for 30 years, if its not for nicotine, Ratzan said. Its the only reason.

And Ratzan argued medical records and pathology reports showed Glogers treating physicians concluded she had lung cancer. He noted one pathology report, on fluid taken from around Glogers lungs, found she had non-small cell carcinoma. It means lung cancer, Ratzan said. And I defy anybody to determine otherwise.

Email Arlin Crisco at acrisco@cvn.com.

Related Information

Watch the trial.

Not a subscriber?

Learn how you can watch blockbuster trials, in Florida and across the country.

See the rest here:
Jury Hands Down $42.5M Total Verdict Against Philip Morris and RJR in Retrial Over Smoker's Cancer Death - CVN News

Virtual Care-The road ahead in healthcare – BusinessLine

Virtual Care, is perhaps the next big wave in healthcare management that is emerging with the US targeting 2030 for realising some tangible applications.

Big data, Genomics, Personalised medicine, Stem Cell therapy and application of tools like Artificial Intelligence will drive dramatic developments in modern medicine that promise to tame many diseases, says David Hayes, Enterprise Medical Director (Provider Relations) , Mayo Clinic Network.

Virtual Care is the delivery of healthcare by harnessing the power of the Smart phone, Computer, tablet, apps etc. There are several efforts globally to develop platforms for reaching benefits of medicine to people, overcoming limitations of geography and physical presence.

At present the norm is Doctor will see you. In 2030, it could be the Patient is dialled in and wants to talk to the doctor, says Hayes. Virtual Care can bring down costs of treatment down in the long term. Patients too can derive benefits of home monitoring the treatment, he told BusinessLine in a recent interaction.

In several developed nations, efforts are on to create platforms so that quality healthcare is conveniently accessible to people wherever and whenever they need. The goal is to reach cost effective, timely treatment, which is reliable too. Virtual Care is mutually beneficial to patients and physicians. Working professionals or the elderly can get the care and medical advise from their homes, instead of a doctor's clinic or a huge corporate hospital visit.

Citing an example, Hayes said, Mayo Clinic, the 155 year old multi-billion dollar healthcare major headquartered in Minnesota, US is working with Google to establish a medical platform, which will see the large resource experts of Mayo and its associates globally linked to help patients. Similarly, Mayo Clinics, itself is utilising its medical expertise and providing tele-healthcare services.

Big data analysis and exploiting the potential of AI will significantly change the medicine of the near future. Drug development will be accelerated with the discovery, clinical trials and feedback become faster, said Hayes, who was in Hyderabad to jointly announce that AIG Hospitals will be the first Indian healthcare group to join the worldwide Mayo Clinic Network.

How reliable is tele-health? This question is important in countries like India, given the infrastructure and other bottlenecks as well as developed countries too. In 2019, the American Medical Association (AMA) has come up with guideline for physicians to ensure quality in delivering Virtual Care. According to reports, the US is projected to face a shortage of a lakh doctors by 2030, which pushes up pressure in healthcare delivery by increasing wait time for patients

Hayes, a noted Cardiologist with contributions in implantable cardiac devices feels, the huge expertise that India has developed in medicine can be leveraged in the development of the cost-effective, efficient systems for Virtual Care as well as in emerging technologies.

Asked about developments in ICDs that can make heart treatment still better, Hayes said Implantable devices have hit a peak. There can at best be incremental improvements. The future is machine to machine communication. More machine based treatments (Robotics) that can improve the quality of care.

See the article here:
Virtual Care-The road ahead in healthcare - BusinessLine

Cell Harvesting Systems Market: Key Players and Production Information analysis – Global Banking And Finance Review

Cell harvesting is a technique of collecting stem cells for regenerate, transplant or repair the damaged organ with healthy functioning ones.Cell harvestingis considered as an important step in biopharmaceutical manufacturing industry that can directly affect the product quality and related downstream processes. Stem cells harvesting helps in treating with diseases namely cancers, blood disorders, immune deficiency diseases and various injuries. This therapy is also beneficial for burn victims which help them in grafting new skin cells as a replacement for damaged ones.

Many companies are focusing on regeneration of myocardial tissue by injection of cell graft consist of adult stem cells from the patients for manufacturing regenerating medicines. For the treatment of eye diseases new healthy cells are also be grown. For harvesting bone marrow a companies are manufacturing devices with passive flexible drilling unit and suction mechanism which will help in reducing the invasiveness of bone marrow transplantation. Cell harvesting system helps in reducing the invasiveness of bone marrow aspiration from the iliac bone with less punctures. Moreover, helps in reducing procedure time and contamination by T-cells.

Request to Sample of Report @https://www.futuremarketinsights.com/reports/sample/rep-gb-1754

Global Banking & Finance Jobs

Cell Harvesting Systems Market:Drivers and Restraints : Cell Harvesting Systems Market are witnessing maximum growth owing to increase bone marrow transplantation procedures attributed to high prevalence of blood cancer and anemia. Moreover, improving healthcare expenditure, survival rate after treatment, increasing investment in logistic services, expansion bone marrow transplant registry for heart along with neuronal disorders and growing per capita healthcare expenditure. However, high cost of cumbersome treatment, lack of reimbursement policies, immunological rejection, viable cell density, and identification of stem cells in adult tissues, and complications during cell harvesting and inadequate number of HSCs cells for transplantation is a major barrier to the cell harvesting systems market.

Cell Harvesting Systems Market:Segmentation : The cell harvesting systems market has been classified on the basis of techniques, application and end user. Based on techniques, the cell harvesting systems market is segmented into the following: Altered Nuclear Transfer, Blastomere Extraction Based on application, the cell harvesting systems market is segmented into the following: Bone Marrow, Peripheral Blood, Umbilical Cord Blood, Adipose Tissue, Based on end-user, the cell harvesting systems market is segmented into the following: Research Centers, Academics Institutes, Diagnostic Labs, Hospitals

Download Table of [emailprotected]https://www.futuremarketinsights.com/toc/rep-gb-1754

Cell Harvesting Systems Market:Overview :Cell harvesting systems market witnessed substantial growth owing to equipment efficacy and accuracy during stem cells harvest. By application type, bone marrow aspiration is anticipated to hold the major share in the cell harvesting systems market owing to less process error, safe and simple procedure and less side effects. People suffering from Leukemia eligible for bone marrow transplant, is expected to contribute highest share in the global cell harvesting systems market. Cell harvesting systems helps in enhancing proper pigmentation in scar reconstruction which encourage companies for continuous technology advancement in both cell isolation techniques and downstream purification processes.

Cell Harvesting Systems Market: Region-wise Outlook : Depending on geographic region, cell harvesting systems marketis segmented into seven key regions: North America, Latin America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa. Asia Pacific dominates the cell harvesting systems marketfollowed by Europe, Japan and North America owing to high concentration of bone marrow stem cells harvesting centers and registries along with skilled doctors for the process of harvesting stem cells in these regions. Asia Pacific, Middle East and Africa hold huge potential and shows substantial growth in terms of wide acceptance of new technologyowing to awareness among population, increasing healthcare expenditure along with high number of potential candidate for the procedure.

Request for [emailprotected]https://www.futuremarketinsights.com/customization-available/rep-gb-1754

Cell Harvesting Systems Market:Key Players :Key players of cell harvesting systems market are PerkinElmer Inc. Tomtec, Bertin Technologies, TERUMO BCT, INC., hynoDent AG, Avita Medical, Argos Technologies, Inc., SP Scienceware, Teleflex Incorporated., Arthrex, Inc., Thomas Scientific, BRAND GMBH

Continued here:
Cell Harvesting Systems Market: Key Players and Production Information analysis - Global Banking And Finance Review